BEUDAMED
    FDA Enforcement Class II Ongoing

    BD SmartSite Bag Access Device Needle-Free Valve, REF: 2300E; BD Bag access Device with 1 Check Valve And Needle Free Valve, REF: 2309E-0006

    Recall: Z-2468-2021 · Reported September 22, 2021

    Enforcement

    Recall Number
    Z-2468-2021
    Event ID
    88203
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CAREFUSION
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 22, 2021
    Initiation Date
    August 2, 2021
    Classification Date
    September 13, 2021
    Address
    10020 Pacific Mesa Blvd, N/A, San Diego, CA, 92121-4386, United States

    Description

    BD SmartSite Bag Access Device Needle-Free Valve, REF: 2300E; BD Bag access Device with 1 Check Valve And Needle Free Valve, REF: 2309E-0006

    Reason

    Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.

    Code Info

    Lots: 20066502 20066503 20066504 20076251 20076352 20086483 20086484 20086485 20086486 20087129 20087130 20096280 20096281 20096282 20096283 20097163 20105074 20105075 20095374 20095375 20096302 20105754 20105755 20105756 20105757 20105758 20115470 21036462 21036463 21036464 21036465 21036466

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of FL, PA, NC, OH, SC, IL, RI, MO, NY, TN, AL, VA, PR, CA, NE, NJ, MI, MD, NM, LA, KY, NV, ME, OK, WA, MA, WV, TX, AR, OR, KS, GA, VT, IN, WY, AZ, CO, MN, WI, UT, SD, MS, ID, MT, ND, HI, IA, DC, AK, NH, CT, DE, GU and the countries of CA, NZ, TW, AU, BE, VN, AR, MY, TH, KR, ID, PH, SG, BH, SA, HK, IN, CN, BR.

    Quantity

    295,331